EUCTR2011-004585-15-DE进行中（未招募）1 期
Single –arm, multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial intraperitoneal catumaxomab followed by chemotherapy regimes - ENGOT-ov8
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer
- •2.Recurrent ovarian cancer disease evaluated by radiographic Response Evaluation Criteria In Solid Tumors (RECIST) criteria or clinically or by CA 125 increase according GCIG-criteria (see below) (maximum 3 recurrences) with current recurrence defined as: progression during platinum-containing therapy or within 6 months after last platinum-containing chemotherapy (platinum resistant or platinum refractory disease)
- •3.Signs for progression either measurable disease according to radiographic Response Evaluation Criteria In Solid Tumors (RECIST) criteria with documented tumor progression or CA 125 increase according the GCIG-criteria (see below) or clinical symptoms of tumor progression according to RECIST criteria.
- •Note: Signs for progression due to CA 125 increase according the GCIG-criteria must be combined with clinical symptoms or diagnostic imaging
- •4.Radiological confirmed ascites (including ultrasound), possible to puncture
- •5.Life expectancy = 12 weeks
- •6.Age = 18 years
- •7.ECOG performance status ? 2
- •8.No prior operation or, in case of prior operation, the patient must be recovered therefrom. The operation must be performed at least 4 weeks prior to start of study drug
- •9.Patients capable of understanding the purposes and risks of the study, who are willing and able to participate in the study, and from whom written and dated informed consent to participate in the study has been obtained before the start of specific protocol procedures
- •10.Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
- •A hysterectomy
- •A bilateral oophorectomy (ovariectomy)
- •A bilateral tubal ligation
- •Is post-menopausal
- •Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for = 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value >40 mIU/mL and an estradiol value < 40pg/mL (<140 pmol/L).
- •Subjects using HRT must have experienced total cessation of menses for >= 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT
- •Negative serum pregnancy test of women of childbearing potential
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 34
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •1.Patients with known brain metastases
- •2.Concomitant cancer, chemo- or radiotherapy (except for local radiation therapy for bone marrow metastases)
- •3.Treatment with any investigational product within 2 weeks prior to first administration of catumaxomab
- •4.In cases of previous exposure to investigational product, cancer-, chemo-, immune- or radiotherapy (except for local radiation therapy for bone marrow metastasis):
- •not sufficiently recovered from previous treatment (toxicity present) based on adequate laboratory values and general status according to other in-/exclusion criteria (i.e. this might be less than 1 or 2 weeks after a weekly or bi-weekly scheduled previous therapy regimen)
- •5.Patients must not have been exposed to nitrosoureas or mitomycin C within 6 weeks prior the first infusion of catumaxomab
- •6.Abnormal organ or bone marrow function as defined below:
- •-absolute neutrophil count (ANC) < 1500 Gpt /l (1,5x 10 9/L, 1500/mm3)
- •-hemoglobin = 9 g/dL
- •-platelet count < 75 Gpt/L (< 75 x 109/L, 75,000/mm3)
- •-Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT /SGPT), > 3 x upper limit of normal (ULN), or > 5 x ULN in cases of metastatic liver disease or
- •alkaline phosphatase (AP) > 2,5 upper limit of normal (ULN)
- •-Serum (total) Bilirubin > 1.5 x ULN or in case of liver metastasis >3 x ULN
- •-Serum creatinine > 1.5 x ULN or = 60 mL calculated according to Cockroft-Gault
- •7.Use of immune-suppressive agents for the past 4 weeks prior to first administration of catumaxomab. For regular use of systemic corticosteroids patients should only be included after stepwise discontinuation to be free of steroids for a minimum of 5 days prior to study entry
- •8.Any known active and chronic infection
- •9.Known infection with human immunodeficiency virus (HIV positive) and / or hepatitis B virus (HbsAg positive) or hepatitis C virus (anti HCV positive)
- •10.Any other concurrent disease or medical conditions that are deemed to interfere with the conduct of the study as judged by the investigator
- •11.Known or suspected hypersensitivity to catumaxomab and its analogues in general
- •12.Known or suspected hypersensitivity to PLD, topotecan, paclitaxel, gemcitabine or their excipients.
- •13.Patients with congestive heart failure New York Heart Association (NYHA) Class III and IV. Cardiac arrhythmias (except atrioventricular block type I and II, atrial fibrillation/flutter bundle brunch block)or other signs and symptoms of relevant cardiovascular disease
- •14.Patients with substance abuse, medical or psychological or social conditions which the investigator believes would preclude compliance with the study requirements.
- •15.Unwilling or unable to follow protocol requirements
- •16.Participation in another clinical study with experimental therapy within 14 days before start of treatment
- •17.Legal incapacity or limited legal capacity
- •18.Subjects housed in an institution on official or legal orders
- •19.Pregnancy or lactation period
研究者
相似试验
进行中（未招募）
1 期
A clinical study exploring the effect of osimertinib and radiation therapy, in people with newly diagnosed non-small cell lung cancer (NSCLC) that has spread to a few other parts of the body and shows a change (mutation) in the EGFR gene.MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Treatment naïve patients with synchronous, oligo-metastatic (primary tumour and maximum 5 metastases) EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC with or without T790M resistance mutationMedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-004114-35-NLETOP IBCSG Partners Foundation60
进行中（未招募）
1 期
A clinical study exploring the effect of osimertinib and radiation therapy, in people with newly diagnosed non-small cell lung cancer (NSCLC) that has spread to a few other parts of the body and shows a change (mutation) in the EGFR gene.Treatment naïve patients with synchronous, oligo-metastatic (primary tumour and maximum 5 metastases) EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC with or without T790M resistance mutationMedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-004114-35-ESEuropean Thoracic Oncology Platform (ETOP)60
撤回
2 期
A multicentre single-arm phase II trial assessing the safety and efficacy of first-line osimertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR-mutant non-small cell lung cancerlungcancerNon small cell lung cancer10038667NL-OMON54434ETOP IBCSG Partners Foundation10
进行中（未招募）
1 期
A clinical study exploring the effect of osimertinib and radiation therapy, in people with newly diagnosed non-small cell lung cancer (NSCLC) that has spread to a few other parts of the body and shows a change (mutation) in the EGFR gene.Treatment naïve patients with synchronous, oligo-metastatic (primary tumour and maximum 5 metastases) EGFR-mutant (exon 19 deletion or exon 21 L858R) NSCLC with or without T790M resistance mutation.MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-004114-35-ITEUROPEAN THORACIC ONCOLOGY PLATFORM60
招募中
不适用
A multicentre single-arm phase II trial assessing the safety and efficacy of first-line osimertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR-mutant non-small cell lung cancerKCT0007170Yonsei University Health System, Severance Hospital13